As is well known, there are electro-medical devices for achieving regeneration and recovery of neuromusculoskeletal injuries based on electrolysis and electro-stimulation.
The treatment based on percutaneous electrolysis currently uses two electrodes, anode and cathode, through which a continuous current is induced into the affected tissue which is located between these electrodes, causing heating and decomposition of the damaged tissue. The main reaction caused by the anode is the decomposition of water, leading to a reduction in the pH in its proximity while the reaction caused by the cathode gives rise to gaseous hydrogen and hydroxyl ions, thus increasing the pH in the proximity of the cathode, causing an aggression to the soft tissues affected, and a subsequent inflammation necessary for initiating the regeneration and recovery process.
The previously mentioned effects, electrolysis and tissue heating depend directly on the density of the current in circulation and the exposure time, where said current density depends on the current generated and the contact surface of the electrode. Electrical stimulation technology, as is known, is based on applying low intensity bipolar electrical impulses and this way stimulating the tissue for analgesic, anti-inflammatory, relaxing or invigorating purposes and therefore accelerating the recovery of damaged tissues.
Known within the state of the art there are electro-medical devices aimed for treating degenerated tissues of the neuromusculoskeletal system based on two electrodes that are physically separated for inducing the flow of galvanic current with the aim of initiating the regeneration of the tissues located between these electrodes, where the cathode is formed by a monopolar needle or an isolated monopolar needle, with or without a Teflon coating, which is applied to the skin in the area comprising the damaged tissue, while the anode is formed by an electrode that may be hand-held or attached to the patient's skin, as seen in the north American U.S. Pat. No. 7,725,193 of the inventor Jennifer Chu or the “Invasive Physio” device by the company Enraf Nonius. In these cases, as the electrodes are physically separated, part of the electrical current destined to treat the injured tissue where the needle is located also flows through part of the healthy tissue surrounding the damaged area, thus reducing the effectiveness of the treatment due to the low targeting of the current in the area to be treated and increasing possible side effects in healthy tissue due to the flow of current through the same. The fact that these devices require this large distance between the anode and cathode increases the bioimpedance existent between the two and leads to the need for applying greater potential difference between the electrodes to obtain the desired current. The electrical bioimpedance is greater because it affects all the tissue located between the two electrodes, both damaged tissue and healthy tissue, a problem which is resolved by the invention to which this document is dedicated.
As a consequence of the galvanic current circulating between the two electrodes along this distance, said current may affect any pathology that it may come across throughout its course, hence in these devices there are contraindications for application on patients with endoprosthesis or osteosynthesis, patients with pacemakers or any electronic implant, patients with heart problems, pregnant women, patients with malignant tumours and/or patients with thrombophiebitis.
There are well-known treatment devices and techniques that use a bipolar signal by means of two electrodes consisting in the use of superficial electrodes or monopolar needles, where depending on the lesion to the tissue to be treated and its depth, an alternating signal may be applied between the two electrodes at a specific frequency, generally of about 100 Hz. At this range of frequencies the bioimpedance of the tissue is very high, hence a very high voltage must be applied between the two electrodes, of about 100 V. These high voltages, which may further increase as the depth of the lesion increases, may affect all the tissue located between the two electrodes, regardless of whether this tissue is healthy or damaged.
On the other hand, there are other devices that use tetrapolar signals which resolve the problem described above, for which high voltages are required for obtaining the desired current due to the high bioimpedance of the tissues at the treatment frequency. These devices are based on generating between a pair of opposed electrodes an alternating current at a frequency comprised between 1.000 and 10,000 Hz. and the other pair of electrodes, positioned at 90° in relation to the previous pair of electrodes, generates the same signal with a frequency offset of about 100 Hz, which is the frequency of treatment and at the intersection of both signals in the area comprising the damaged tissue to be treated is where both signals are combined, generating a modulated signal at the frequency resulting from the frequency offset between the stimulation currents and this way, the electrical bioimpedance of the tissue is much lower and this avoids the need for applying high voltages to obtain the desired current. Even so, there remains the same problem as seen in the previous cases of the currents generated affecting all the tissue located between the electrodes, both healthy and damaged tissue, and the size of said affected tissues may be even greater the deeper the lesion. Also remains the case of not permitting its use on patients with endoprosthesis and osteosynthesis, patients with pacemakers or any electronic implant, patients with heart problems, pregnant women, patients with malignant tumours and/or patients with thrombophiebitis.
Widely known is the device of the U.S. Pat. No. 6,058,938 of the inventors Jennifer Chu and Peter Styles that uses a bipolar needle as the electrode and a superficial electrode as the return electrode for performing an electro-stimulation on the patient for the purpose of the patients experiencing less pain and discomfort during the procedure after the initial insertion of the needle, but unlike the invention referred to in this document in the case of attempting to stimulate a deep tissue part of the healthy tissue will be affected and the effectiveness of the treatment will be reduced. In addition to not having the ability to diagnose the degree of degeneration of the injured tissue for calculating the necessary current for treating said tissue.
There are patents and devices which use tissue impedance readings for location and treatment using acupuncture not presenting the ability for self-diagnosis for determining the degree of degeneration present in the examined tissue or means for adjusting the treatment signal while also deferring the use of the electrodes, and are therefore different to the invention referred to herein.
After reviewing the state of the art, there is the need for an electro-medical device that is capable of providing diagnosis and treatment by electrolysis or electro-stimulation of damaged tissues of the neuromusculoskeletal system targeted on the area comprising the damaged tissue to be treated without affecting the surrounding healthy tissue, a situation that has not been resolved in the state of the art. Consequently, the invention object of this patent allows to obtain the same treatment while reducing the electrical current required due to reducing the area of treatment, with less current applied we achieve the same density of current in the area of treatment and also obtain a more accurate and lower reading of the electrical bioimpedance value, as the electrical bioimpedance of the healthy tissue is not added, which prevents from having to apply high voltage for achieving the necessary current and also eliminates the contraindications present in the current devices for the treatment as described above.